TruCOMMS-CE Mark Approval
Aortech International PLC
21 August 2000
AorTech International plc
TruCOMMS - CE Mark approval
AorTech International plc, the Scottish-based manufacturer of
cardiovascular devices, announces European Regulatory, CE Mark
approval in respect of TruCOMMS, the Continuous Cardiac Output
Monitoring System.
CE Mark approval enables AorTech to commence marketing TruCOMMS
throughout Europe and initially it will be targeted towards UK,
Germany and Italy. This follows on from FDA approval last year for
the North American market place.
Dr. Peter Duijst, AorTech's Medical Director, commented:
'With the satisfactory conclusion of final clinical trials, held
in conjunction with Papworth Hospital, Cambridge, UK, the TruCOMMS
system represents a major breakthrough in monitoring patients
cardiac output both during and after surgery. In addition to
obtaining European Regulatory Approval for our product, a
presentation on TruCCOMS at the Annual Meeting of the Association
of Cardio Thoracic Anaesthetists held in Cambridge last April, won
first prize, TruCCOMS being described as a safe and effect device
for continuous real time monitoring of cardiac output on
critically ill patients.
'Recognising the tremendous advantages, which include ease of use
and potential cost savings over existing heart monitoring systems,
several major hospitals in Italy, Germany and the United Kingdom,
have requested our product for use both during and after surgery.
'The main clinical advantage of TruCOMMS over other systems is
through the immediacy of its response to cardiac output changes.
Those in the medical field who deal with critical and surgical
care patients can for the first time monitor cardiac performance
directly, enabling the immediate recognition of any changes in
cardiac output, including during surgery - such technology could
help save lives.'
Enquiries:
AorTech International plc 01698 746699
Eddie McDaid, Managing Director
Ian Cameron, Finance Director
Dr. Peter Duijst, Medical & Regulatory Director
College Hill Associates 0207 4572020
Michael Padley / Nicholas Nelson
www.aortech.com
Copies of this statement will be available for a period of 14 days
from the Company's registered office:
Phoenix Cresent, Strathclyde Business Park, Bellshill, Scotland
ML4 3NJ